Postoperative IleusPhase 3NCT01710982
Study to Evaluate the Safety of Post-Operative TZP-101 (IV Ulimorelin) After Partial Bowel Resection
A Phase 3 study testing TZP-101 in people with Postoperative Ileus, run by Norgine.
Trial summary
A study to evaluate the safety of TZP-101 in comparison with placebo when administered post-operatively in patients who have undergone partial bowel resection. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Ileus
- What is being tested?
- TZP-101
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- Feb 2012to Apr 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is 18 to 80 years of age, inclusive.
- Patient is scheduled to undergo open bowel resection.
- Female patients must be postmenopausal (for at least 1 year), surgically sterile, practicing true sexual abstinence, OR must be using adequate contraception (in the opinion of the investigator) for the duration of the study, including the follow-up period (e.g. contraceptive implants, injectables, oral contraceptives, some intrauterine devices [IUD], and/or barrier method (condom or occlusive cap) with spermicidal foam/gel/film/cream/suppository).
- Hormonal and IUD methods of contraception must be established for a period of 3 months prior to dosing and, if changed, alternative methods should be used as directed by the investigator throughout the duration of the study.
- Females of childbearing potential must have a negative pregnancy test at screening and admission
- After surgery and prior to administration of the first dose of study drug, the following eligibility criteria must be assessed:
- Patient underwent open bowel resection.
- Patient has given written informed consent
Who cannot join
- Patient weighs more than 200kg (441 pounds).
- Patient is classified as American Society of Anesthesiologists (ASA) Class 4, 5, or 6
- Patient has complete bowel obstruction.
- Patient is scheduled to receive a low rectal or anal anastomosis (e.g. proctectomy or ileoanal anastomosis) (low rectal is defined as below the anterior peritoneal reflection - typically 9-10cm from the anal verge).
- Patient is scheduled for laparoscopic or laparoscopic hand-assisted procedure.
- Patient's surgical procedure is considered to be an emergency procedure.
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- Patient has significant impairment of liver or renal function (alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) 2.5 times the upper limit of normal; creatinine clearance <30mL/minute (min), estimated using serum creatinine with the formula [(140 - age in years) × weight in kg]/[(72 × serum creatinine in mg/dl) × 0.85 for female patients].
- Patient is anticipated to require prolonged post-operative ventilation.
- Patient has a psychiatric disorder or cognitive impairment that, in the opinion of the Investigator, would interfere with participation in the study.
- Patient has participated in an investigational drug study 30 days prior to the study initiation.
- Patient has a positive laboratory test result for controlled substances (other than for those prescribed by a medical professional and/or accounted for by concomitant medications) at screening.
- Patient is known to have Hepatitis B or Hepatitis C infection currently associated with clinically significant symptoms or abnormal liver function.
- Patient has a recent, adult history of clinically significant hypersensitivity reaction(s) to any drug, in the opinion of the Investigator.
- Patient is pregnant (confirmed by pregnancy test) or is breastfeeding.
- Patient has known history of drug or alcohol abuse within the previous year.
- After surgery and prior to administration of the first dose of study drug, the following eligibility criteria must be assessed:
- Patient received a low rectal or an anal anastomosis (e.g. proctectomy or ileoanal anastomosis) (low rectal is defined as below the anterior peritoneal reflection - typically 9-10cm from the anal verge).
- Patient underwent a laparoscopic procedure (including a hand-assisted laparoscopic procedure).
- Patient is classified as American Society of Anesthesiologists (ASA) Class 4, 5, or 6.
- Patients has received ulimorelin previously
About this study
Official title: A Multicentre, Randomised, Double-blind, Placebo-Controlled Study to Evaluate the Safety of TZP-101 (IV Ulimorelin) Administered Post-Operatively in Patients Who Have Undergone Partial Bowel Resection
A study to evaluate the safety of TZP-101 in comparison with placebo when administered post-operatively in patients who have undergone partial bowel resection.
Read the detailed description
This was a multicenter, multinational, randomized, parallel, double-blind, placebo-controlled study to evaluate the safety of TZP-101 administered post operatively to male and female patients aged 18-80 years of age who had undergone partial bowel resection.
It was anticipated that 330 patients would be dosed with once-daily IV administration of 480 mcg/kg TZP-101 or placebo on a 2:1 ratio. An approximately 7% loss of eligible patients between randomization and dosing was expected, therefore it was anticipated that approximately 355 patients would be randomized onto the trial.
This study consisted of a screening period, an in-patient treatment period and a follow-up phone call. The follow-up phone call was to be performed 14 days (+/- 2 days) after the last study drug administration and a follow-up clinic visit 32 days after the last study drug administration. The overall study duration for each patient was not expected to exceed 63 days.
Dosing was to be once daily, commencing within one hour following surgery and continuing every 24hrs (+/- 2hrs) until the first BM, up to a maximum of 7 doses for all patients.
- Conditions
- Postoperative Ileus
- Being tested
- TZP-101, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TZP-101Drug
Also called Ulimorelin HCl monohydrate (ulimorelin·HCl·H2O)
PlaceboOther
Also called Placebo (5% dextrose solution in Water for Injection)
| Study group | Role | What they receive |
|---|---|---|
| TZP-101 | Active comparator | TZP-101 Receives: Drug: TZP-101 |
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment Emergent Adverse Events as a Measure of Safety and Tolerability
To evaluate the safety of TZP-101 in comparison with placebo when administered post-operatively in patients who have undergone partial bowel resection.
Measured: 32 days post-dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2012 (estimated)
- Study startFeb 2012
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative IleusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norgine
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sandy Eisen, MD, Study director, Norgine Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01710982
- Sponsor's protocol ID
- NPJ5004-04/2011 (SDS)
- Status last verified
- Sep 2024
- First submitted
- 14 Sep 2012
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Randomised, Double-blind, Placebo-Controlled Study to Evaluate the Safety of TZP-101 (IV Ulimorelin) Administered Post-Operatively in Patients Who Have Undergone Partial Bowel Resection
- ClinicalTrials.gov ID
- NCT01710982
- Acronym / sponsor ID
- NPJ5004-04/2011 (SDS)
- Conditions
- Postoperative Ileus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- NorgineIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 19 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to evaluate the safety of TZP-101 in comparison with placebo when administered post-operatively in patients who have undergone partial bowel resection.
Detailed description
This was a multicenter, multinational, randomized, parallel, double-blind, placebo-controlled study to evaluate the safety of TZP-101 administered post operatively to male and female patients aged 18-80 years of age who had undergone partial bowel resection.
It was anticipated that 330 patients would be dosed with once-daily IV administration of 480 mcg/kg TZP-101 or placebo on a 2:1 ratio. An approximately 7% loss of eligible patients between randomization and dosing was expected, therefore it was anticipated that approximately 355 patients would be randomized onto the trial.
This study consisted of a screening period, an in-patient treatment period and a follow-up phone call. The follow-up phone call was to be performed 14 days (+/- 2 days) after the last study drug administration and a follow-up clinic visit 32 days after the last study drug administration. The overall study duration for each patient was not expected to exceed 63 days.
Dosing was to be once daily, commencing within one hour following surgery and continuing every 24hrs (+/- 2hrs) until the first BM, up to a maximum of 7 doses for all patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TZP-101 | Active comparator | Drug: TZP-101TZP-101 |
| Placebo | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient is 18 to 80 years of age, inclusive.
- Patient is scheduled to undergo open bowel resection.
- Female patients must be postmenopausal (for at least 1 year), surgically sterile, practicing true sexual abstinence, OR must be using adequate contraception (in the opinion of the investigator) for the duration of the study, including the follow-up period (e.g. contraceptive implants, injectables, oral contraceptives, some intrauterine devices [IUD], and/or barrier method (condom or occlusive cap) with spermicidal foam/gel/film/cream/suppository).
- Hormonal and IUD methods of contraception must be established for a period of 3 months prior to dosing and, if changed, alternative methods should be used as directed by the investigator throughout the duration of the study.
- Females of childbearing potential must have a negative pregnancy test at screening and admission
Key exclusion criteria (20 listed)
- Patient weighs more than 200kg (441 pounds).
- Patient is classified as American Society of Anesthesiologists (ASA) Class 4, 5, or 6
- Patient has complete bowel obstruction.
- Patient is scheduled to receive a low rectal or anal anastomosis (e.g. proctectomy or ileoanal anastomosis) (low rectal is defined as below the anterior peritoneal reflection - typically 9-10cm from the anal verge).
- Patient is scheduled for laparoscopic or laparoscopic hand-assisted procedure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TZP-101Also: Ulimorelin HCl monohydrate (ulimorelin·HCl·H2O) | Drug | TZP-101 |
| PlaceboAlso: Placebo (5% dextrose solution in Water for Injection) | Other | Placebo |
Primary outcome
Number of Participants with Treatment Emergent Adverse Events as a Measure of Safety and Tolerability
Time frame: 32 days post-dosing
To evaluate the safety of TZP-101 in comparison with placebo when administered post-operatively in patients who have undergone partial bowel resection.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandy Eisen, MD study director
Norgine Ltd
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TZP-101 in people with Postoperative Ileus, run by Norgine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Treatment Emergent Adverse Events as a Measure of Safety and Tolerability (time frame: 32 days post-dosing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.